Brand Name | NELLCOR |
Type of Device | PULSE OXIMETER |
Manufacturer (Section D) |
MEDIANA |
wonju industry park; dongwha-r |
gangwon-do |
TH |
|
Manufacturer (Section G) |
MEDIANA |
wonju industry park; dongwha-ri,munmak-eup, wonju-s |
|
gangwon-do |
TH
|
|
Manufacturer Contact |
thom
mcnamara
|
15 hampshire street |
mansfield, MA 02048
|
5084524811
|
|
MDR Report Key | 4862213 |
MDR Text Key | 17204184 |
Report Number | 2936999-2015-00551 |
Device Sequence Number | 1 |
Product Code |
DQA
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K822909 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
06/02/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | PM100N |
Device Catalogue Number | PM100N |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/02/2015
|
Initial Date FDA Received | 06/23/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/18/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|